This invention related generally to devices for locating, inserting, and holding catheters to be implanted in patients and, more particularly, to a Composite Catheter Assembly for fixing, locating, inserting, and accurately securing intravenous catheters within body fluid-carrying conduits, preimplanted grafts, and the like in patients, and for the controlled retracting of such catheters from the inserted position in such body fluid-carrying conduits under safe, reliable, and aseptic conditions.
When used herein catheter or catheter assembly or variations thereof is intended to include an intravenous catheter having a combination of elements for passing fluid to or from a fluid carrying conduit or blood vessel in a patient. Such intravenous catheters generally include a tubular conduit having a first connector at one end for connecting the tubular conduit to a source of enteral fluid for delivery to the patient or a reservoir for receiving fluid from the patient and a second connector at the end opposite from the first connector, and an elongated hollow needle having a head end for fixedly or removably connecting the needle to the second connector and a pointed end for inserting the needle into the fluid carrying conduit or blood vessel of the patient.
In the medical field the intravenous insertion of catheters, cannulas and the like into a patient generally require some means to secure the catheter or cannula in place for the period of use. This has generally been done by positioning a gauze pad and/or by the application of strips of tape for securing the catheter and associated tubing to the patient so as to prevent any accidental removal of the catheter by sudden or accidental movements of the patient. This technique is not acceptable because the placement of the catheters or cannulas is entirely non-uniform and becomes a hit or miss proposition so that proper placement of the catheter is clearly not insured. Further, such placement is quite slow and is dependent upon the ability of the nurse or other technician who is applying the catheter or cannulas to the patient.
Furthermore, the handling of needles, catheters and cannulas by nurses and other medical personnel has posed a serious problem in today's society with the onset of infectious diseases and with the problem of AIDS. Medical personnel have been known to contract the disease AIDS and other infectious diseases by accidentally pricking themselves with needles used for insertion into patients either upon taking the needle out or at times putting the needles into the patient. There has thus been a continuing search for new devices to replace the present prior art type devices so as to insure proper application, and securing of the catheters, cannulas or other needle type devices inserted into the patient, and to protect the medical personnel from accidental contact with various infectious diseases and, in particular, the AIDS virus.
The prior art has, in this crowded art, developed many devices seeking to accomplish this desirable end such as those shown in U.S. Pat. Nos. 2,402,306; 3,021,842; 3,288,137; 3,900,026; 4,170,993; 4,316,461; and 4,332,248.
In particular, for example U.S. Pat. No. 4,170,993 to Alvarez discloses a sliding intravenous needle carrier assembly which includes, a delta-shaped base plate with an open ended barrel secured to the base plate. An intravenous needle carrier is slidingly received within the barrel. The carrier is provided with a manually movable lateral projection which extends through a slot in the barrel so that the carrier with the needle can be manually moved between its forward position until the lateral projection falls into a forward detent so that the needle is fully extended through the front open end of the barrel; and its rearward retracted position in which the lateral projection falls into a rear detent and the needle is completely retracted in the barrel. Rotating the grasping projection of the needle carrier in the detent locks the needle carrier in either the rearward or forward position. The base plate is anchored to the patient's skin by means of adhesive strips after the needle is inserted into the blood vessel.
There is no adjustable angular positioning mechanism in the Alvarez patented device to insure appropriate angular entry of the needle, nor is there any non-contracting mechanism for retracting the needle to protect medical personnel from direct contact with the pointed end of the needle on the catheter. In addition, the anchoring means of U.S. Pat. No. 4,170,933 is affixed to the patient after insertion of the needle.
The prior art also discloses angular entry of the catheter as disclosed in U.S. Pat. No. 2,402,306 to Turkel. This patent includes, an anchoring or base support for the catheter with side extending leaf members which can be attached by tape or the like to the patient. The support includes means for angular entry of the needle and in the embodiment shown in FIGS. 4, 5, 9 and 10, thereof, there is a provision for altering the angle of the needle. However, as in the other prior art devices, it still becomes necessary to try to carefully aim the catheter into the desired injection site and no physical means are provided for insuring that the catheter is properly placed and aligned with the preimplanted graft or the like.
The search, therefore, continues for a practical device which can accurately and securely assist in fixing the intravenous catheter in place, not only by permitting insertion at precisely the right location, angle and depth, but which can also firmly secure the catheter in place without additional difficulty and will protect the nurse or other medical personnel from contact with body fluid that may remain in the exposed needle when the intravenous catheter is retracted and removed.
The present invention provides an improved Composite Catheter Assembly for meeting and overcoming these problems of the prior art wherein an anchoring or attachment plate with an elongated longitudinal opening thereon can be aligned and affixed to the patient at the site of a fluid carrying conduit, a barrel member is pivotally connected to the attachment plate in the longitudinal line of the elongated opening and has a bore extending inwardly from one end of the barrel at least a portion of length of said barrel to form an opening at the end thereof and a transverse shoulder at the opposite end to permit a sized opening to be formed in that end of the barrel so that the bore communicates with the exterior of the barrel, and a catheter assembly slidably mounted in the bore of the barrel for movement from a retracted position to an extended position in which the needle end of the catheter assembly will extend through the sized opening in the barrel and project past the longitudinal opening in the attachment plate for accurate insertion into the fluid carrying conduit of the patient, the catheter assembly including, a latch assembly having, a resilient member which is compressed when the catheter assembly is moved to the extended position, and a locking means having a release lever pivotally connected to the barrel and operative to hold the catheter assembly in the extended position and adapted on manual movement so that the resilient member can retract the catheter assembly and withdraw the entire needle safely into the bore of the barrel.